Presentation (CTI)

OBJECTIVES: Since introducing a health technology assessment (HTA) system in 2006 to support value-based drug reimbursement, Korea has adopted alternative pathways to improve patient access. However, increasing reliance on the Economic Evaluation Exemption (EEE) mechanism raises concerns about HTA framework coherence and long-term sustainability. This study explores how and why pharmacoeconomic evaluation (PE) is used less frequently in reimbursement decisions and examines whether the current HTA system operates as intended based on qualitative insights from industry professionals.
METHODS: A focus group discussion was conducted with 13 PE professionals experienced in drug pricing and reimbursement processes. The discussion was transcribed and analyzed using thematic content analysis to identify key themes and patterns.
RESULTS: Four principal themes emerged from the qualitative analysis: (1) erosion of value-for-money principles in decision-making processes; (2) structural and functional limitations inherent in the evaluation framework; (3) inadequate transparency and inconsistency in assessment procedures; and (4) inappropriate utilization of the managed entry agreements (MEA). Participants indicated that PE system has become a price-cutting tool rather than examining the genuine value in reimbursement decisions. Rigid methodological requirements and inflexible assessment criteria create barriers to capturing multidimensional value of innovative therapeutics, particularly for rare diseases and breakthrough therapies. Procedural opacity, inconsistent reviewer requirements, and the absence of ultimate decision-maker during PE review process collectively undermine reimbursement predictability. MEAs including EEE and risk-sharing agreements have deviated from managing clinical uncertainty to merely distributing budget constraints
CONCLUSIONS: Current reliance on alternative pathways undermines the systematic evidence-based approach that HTA was designed to support. Addressing these issues requires revising the normative foundations of PE system, clarifying policy goals and ensuring broader reimbursement value alignment with core HTA principles.